Program Overview
New Insights Into the Current Issues and Associated Challenges Impacting Drug Safety.
Top pharmaceutical, biotech, and regulatory representatives will discuss the current complexities and controversies in pharmacovigilance and risk management throughout all phases of development and marketed use, new and updated legislation in various ICH regions, important new harmonization initiatives, life cycle management, the impact of social media, biosimilars, and the use of other data sources and observational research. This program will focus primarily on drug products and biologics.
Featured Topics
- Regulatory Day
- New European, US, and Japanese Legislation
- New Harmonization Initiatives
- Risk Management/Life Cycle Management
- REMS
- Early Understanding of Clinical Safety and Risk
- Benefit-risk Analysis
- Social Media
- Biosimilars
- Data Sources and Observational Research
Learning Objectives
At the conclusion of this meeting, participants should be able to:
- Describe the latest regulatory framework for pharmacovigilance in the US, Europe, and Japan
- Discuss new safety harmonization initiatives
- Describe best practices for improving risk management and life cycle management approaches
- Discuss how companies are using social media to investigate safety information in the context of regulatory obligations
- Explain how to use other data sources and observational research for effective safety analysis
Who Should Attend
Professionals involved in:
- Pharmacovigilance
- Risk Management
- Medical Product Safety Assessment
- Regulatory Affairs
- Clinical Research
- Data Analysis
- Pharmacoepidemiology
- Labeling
- Quality Assurance/Quality Control
- Compliance
- Medical Information
Event Information
Contact Ellen Diegel, Program Manager
Phone +215-293-5810, Fax +1.215.442.6199, email Ellen.Diegel@diahome.org
Phone +215-293-5810, Fax +1.215.442.6199, email Ellen.Diegel@diahome.org
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